Health Condition 1: null- Dental Pain following tooth extraction
Conditions
Interventions
Intervention1: Fixed Dose of Diclofenac 50mg plus Paracetamol 500 mg: One Tablet Twice a day
Control Intervention1: Ibuprofen 400 mg: One Tablet Three Times A day
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients needing extraction for impacted third molars under local anesthesia. 2.Between the ages of 18 to 45 years. 3. In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation). 4. Willing to undergo observation period for three hours post-extraction. 5. Willing for telephonic follow up. 6. Ability to complete a 10 cm visual analog scale and a category scale every 30 minutes for the first 3 postoperative hours.
Exclusion criteria
Exclusion criteria: 1. Surgical Time in excess of 45 minutes. 2. Patients with known hypersensitivity to any of the study drugs. 3. Patients with any contraindication to the study drugs. 4. Patients who are pregnant or nursing. 5. Patients with history of peptic ulcers and/or GI bleeding. 6. Patients who have significant psychiatric history. 7. Patients with severe kidney/ liver disease. 8. Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; coumarin or other blood thinners. 9. Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery). 10. Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomization. 11. Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity difference at 8 hours (PID8), Time to maximum PID (tmaxPAID), Pain relief scores at 24, 48 hours (PR24, PR48) and on day 4 (PRday4), Global efficacy by patients and investigator, Rescue analgesia requirement.Timepoint: The pain intensity shall be assessed at baseline, 30min, 60min, 2hrs, 4 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs and on 4th post extraction day. | — |
Primary
| Measure | Time frame |
|---|---|
| Time to onset of analgesia, Time to Maximum Pain relief (tMaxPR), Pain relief at 8 hrs (PR8).Timepoint: After Administration of Study Medication. | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Medical Services.
Outcome results
None listed